DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1, 13 and 14 objected to because of the following informalities: these claims refer to both an “elongated” medical instrument and an “elongate” medical instrument. A single one of these terms should be used, to avoid confusion as to whether multiple instruments are claimed. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
Claims 1-3, 5-6, 10, 12-13, 15, 17-19 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 2008/0277445 A1 to Zergiebel et al. (hereinafter “Zergiebel”).
Regarding Claims 1, 13 and 19, Zergiebel teaches a hand powered rooter for introducing an elongated medical instrument into a body of a subject (see Examiner-annotated FIG. 1 below), comprising:
a housing (16)
a rotatable element disposed within the housing and rotatable about a longitudinal axis (see Examiner-annotated FIG. 1 below), wherein the elongated medical instrument is couplable to the rotatable element (see Examiner-annotated FIG. 1 below, and Paras. 26-27); and
an actuator (see Examiner-annotated FIG. 1 below; the actuator may be considered the combination of block 40 and pin 42) including an internal element (e.g. block 40) positioned around the rotatable element, wherein longitudinal movement of the internal element along the longitudinal axis causes the rotatable element to spin (see e.g. Examiner-annotated FIG. 1 below and Para. 24);
a manual trigger having a first end pivotably attached to the actuator (see Examiner-annotated FIG. 1 below),
a handle extending from the housing (see Examiner-annotated FIG. 1 below), and
an intermediate member cantilevered from the handle (see Examiner-annotated FIG. 1 below);
wherein a second end of the manual trigger trigger is pivotably attached to a distal end of the intermediate member (see Examiner-annotated FIG. 1 below);
wherein translating the first end of the manual trigger proximally along the longitudinal axis causes longitudinal movement of the internal element in a proximal direction relative to the handle to effect rotation of the elongate medical instrument (see e.g. “A drive block 40 surrounds rotator rod 36 and is engageable with helical flute 38 so as to rotate rotator rod 36 as drive block 40 is moved in the distal and proximal directions relative to handle housing 16. In order to move drive block 40 in the proximal and distal directions, drive block 40 includes a pin 42 which is configured to ride within slot 32 in trigger 24. Thus, as trigger 24 is depressed, pin 42 moves within slot 32 and draws drive block 40 proximally over helical flute 38 thereby rotating drive rod 36 in a first direction. Once trigger 24 has been fully depressed, it returns to the initial position due to the bias of spring 30 causing drive block 40 to move distally back over helical flute 38 on drive rod 36” in Para. [0024])
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Regarding Claim 2, see at least the elongated internal space/cavity of the housing which receives the actuator; this space/cavity equates to an elongated slot that receives the actuator.
Regarding Claims 3, 10, 12, 15 and 17, Zergiebel further teaches wherein the rooter includes a return element configured to return the actuator in a distal direction along the longitudinal axis to an initial position upon release of the manual trigger by an operator and positioned within the housing and coupled to the handle of the rooter (see return element 30 in Examiner-annotated FIG. 1 of Zergiebel above).
Regarding Claims 5-6 and 18, see helical flute 38 of Zergiebel.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 7-9, 11, 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zergiebel in view of US Patent No. 4,524,650 to Marks (hereinafter “Marks”).
Regarding Claims 7-9 and 20 Zergiebel fails to teach that the “member” discussed above is “a pair of spaced apart members located on opposite sides of the internal element” and “wherein the internal element is hingedly coupled to the pair …” Rather, it generally appears from FIG. 1 that Zergiebel’s trigger 24 hingedly attaches to the pin 42 and/or block 40 via one point of attachment instead of two. However, as a general matter, creating a stronger and more stable hinged attachment via the use of two spaced apart attachment points is remarkably well known in a variety of mechanical arts including handheld and hand-actuated surgical tools. As an example, attention is directed to the Marks reference which teaches a very similar actuator structure as seen in Zergiebel in which a trigger is squeezed to move an actuator (24) proximal over a rotatable element (12), including several hinged connections using an internal element/pin (see hinged connections in the annotated FIG. 1 below; also see how lever 52 is coupled to slider 24 by means of a pin 54 in FIG. 2), i.e. similar to Zergiebel’s pin 42, in which the pin is seen to hingedly coupled to spaced apart members (e.g. on a trigger element such as trigger 48) on opposite sides of the pin (see annotated FIG. 1 below). As one of ordinary skill in the art would readily understand and appreciate, the spaced apart members seen in Marks allow for the hinged connections to each have two attachment point (i.e. at opposing ends of each hinge/pin), which provides additional stability and helps keep the connection secure. Accordingly, it would have been obvious to one of ordinary skill in the art as of the filing date of the invention to modify the top end of Zergiebel’ s trigger to branch into opposing spaced apart members for coupling to opposite sides of the internal element/pin, because doing so would enhance the structural stability of the connection (via providing two attachment points as opposed to one) while preserving the same overall functionality, and furthermore because Marks illustrates that it was known to provide such a hinged connection in a similar device
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Regarding Claims 11 and 16, as noted above, Zergiebel teaches a return element 30, but fails to specifically teach that the return element is “disposed about the rotatable element proximal of the actuator.” Marks teaches a very similar actuator structure as seen in Zergiebel in which a trigger is squeezed to move an actuator (24) proximal over a rotatable element (12) and in which a return element (return spring 38) is disposed about the rotatable element proximal to the actuator (seen in FIG. 2). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Zergiebel to reposition the return element to be about the rotatable element proximal of the actuator, as taught by Marks, because it would amount to a mere rearrangement of the same part from one known location (as seen in Zergiebel) to another known location (as seen in Marks) while retaining its same function (i.e. because the return spring functions identically in both Zergiebel and Marks despite having a different location). One of ordinary skill would understand how to make the necessary size and shape adjustments to avoid mechanical interference between moving parts of the device, e.g. by making the diameter of the spring large enough to avoid interference from the helical flute 38.
Another rationale for why this would be obvious is that the relocation of the return element to a location further from Zergiebel’s hinge point 26 would predictably either (1) increase the possible/available torque that could be applied to hinge point 26 (if using the same spring), and/or (2) allow the use of a less powerful (and thus less expensive) spring to achieve the same torque, since the torque produced by the return element at the hinge is dependent on the distance away from the hinge.
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Zergiebel as applied to claims 3 and 13 above, and further in view of US 2009/0270862 A1 to Arcenio (hereinafter “Arcenio”).
Regarding Claims 4 and 14, Zergiebel teaches a one-way ratcheting mechanism achieved by using clutch 50, described in e.g. Paras. 26-27. The end result is that when the user releases the trigger 24, the actuator 40+42 is allowed to move in the distal direction to return to its original position without causing the elongated medical instrument 60 to also rotate back to its original position (i.e. the same end result as Applicant’s claimed mechanism, namely a one-way ratcheting mechanism). However, one minor difference is that Zergiebel’s mechanism allows the rotatable element 36 to return to its original position as the actuator returns back to its original position; specifically, the clutch 50 allows the rotatable element 36 to rotate back while allowing the elongated instrument 60 to remain rotationally stationary. As such, Zergiebel fails to teach that movement of the actuator to its original position “does not cause the rotatable element to spin or oscillate.”
However, Arcenio demonstrates a very similar device including a similar one-way ratcheting mechanism (generally referred to as “rotation-limiting mechanism 132” which can be a clutch mechanism per Para. 67) in which the rotatable element (130) within the housing is not allowed to rotate while the actuator is returned to its original position via the force from a spring (see e.g. Para. 71). Arcenio thus demonstrates that the same end result can be achieved using a very similar rotation limiting mechanism in which the rotatable member within the housing can be held rotationally still while the handle and actuator are returned (via the spring) to their original positions. One skilled in the art would recognize that Arcenio’s overall arrangement of the rotation limiting mechanism is a suitable alternative to Zergiebel’s arrangement of the rotation limiting mechanism since they both ultimately produce the same one-way ratcheting effect. As such, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Zergiebel to utilize a rotation-limiting mechanism which keeps the rotatable member rotationally still while the handle and actuator are returned (via the spring) to their original positions, as taught by Arcenio, since this would involve merely exchanging one known rotation-limiting mechanical arrangement for a very similar known rotation-limiting mechanical arrangement which predictably achieves the same result.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,171,456. Although the claims at issue are not identical, they are not patentably distinct from each other because they recite the same invention in nearly identical language.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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